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Category: Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA)

Understanding ALCOA Principles in Clinical Trials: The Foundation of Data Integrity and Compliance

Posted on May 2, 2025 digi By digi

In the context of clinical trials, maintaining the quality and credibility of data is crucial for ensuring participant safety, achieving reliable results, and supporting regulatory submissions. ALCOA principles serve as the foundation for good documentation practices (GDP) under Good Clinical Practice (GCP) standards. Compliance with ALCOA ensures that every data point collected during a study can be trusted and verified independently.
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Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA), Data Integrity and ALCOA+ Principles

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